|- candidate number||7824|
|- NTR Number||NTR2241|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-mrt-2010|
|- Secondary IDs||313080401 ZonMW|
|- Public Title||Prevention and cure of depression in community dwelling elderly.|
|- Scientific Title||Better access to cure and care for (sub)clinically depressed elderly.|
|- ACRONYM||Lust for Life|
|- hypothesis||The stepped care programme which aims to prevent clinical depression in frail elderly with a subclinical depression, and reduces the level of depressive symptoms in frail elderly with a clinical depression is applicable in primary care.
|- Healt Condition(s) or Problem(s) studied||(Sub)clinical depression|
|- Inclusion criteria||Frail elderly persons of 65 years or older living in the community with a CES-D score (Centre for Epidemiological Studies Depression) of 16 or higher.|
|- Exclusion criteria||1. Insufficient mastery of the Dutch language;|
2. Unwilling or unable to give informed consent.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2010|
|- planned closingdate||1-apr-2013|
|- Target number of participants||450|
|- Interventions||We will use a stepped-wedge cluster-randomised design. This means that by the end of the study all participating general practices will eventually work according to the implementation programme, but the starting moments (experimental condition) are phased and determined at random. In total, 80 general practices will be randomised in 4 clusters of 20 with starting dates spaced 4 months apart. During the waiting period, care as usual will be provided (i.e. control condition).
Phase 1 of our stepped-care programme comprises psycho-education and motivational interviewing. In phase 2, participants can choose from bibliotherapy or an exercise programme. In phase 3, participants can choose from Reminiscence Therapy or Problem Solving Treatment. In phase 4, participants will be referred to treatment in an out-patient clinic.
Every intervention takes three months, and will be provided by nurse practitioners (apart from the exercise programme). After every phase, the nurse practitioner will use the CES-D to determine whether depressive symptoms persist. If so, participants will be offered the next part of the programme.
|- Primary outcome||Applicability of the researchprotocols that have been developed in research studies, in terms of numbers of persons treated.
Also, after the implementation of each phase (each phase takes three months), an evaluation will take place with participants and care providers to evaluate the programme. At the end of the implementation programme (i.e. after 24 months), a group discussion will take place between all participants involved, including representatives of the elderly.
|- Secondary outcome||Clinical effectiveness of the stepped care programme.
|- Timepoints||At baseline, and at 3, 6, 9, 12, 18 and 24 months.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| I.M.J. Beljouw, van|
|- CONTACT for SCIENTIFIC QUERIES|| P.J. Veer-Tazelaar, van 't|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Aim of the study is to examine the applicability of the research protocols that have been developed in research studies.|
Secondly, the present study will evaluate the effects of the generic stepped care programme, offered by nurse practitioners, to prevent and reduce the incidence of depression in community dwelling frail elderly in the Netherlands.
|- Main changes (audit trail)|
|- RECORD||8-mrt-2010 - 23-mrt-2010|